12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616733
• Other study ID #: CS0777-A-U102
• Secondary ID: IND 77,409
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2008
• Last updated: March 9, 2011
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)

• Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months

• Baseline EDSS score of 0 - 6.5

• Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception

Exclusion Criteria:

• Primary progressive MS

• Any medical condition that predisposes to immunocompromise

• History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection

• Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)

• Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation

• Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation

• Treatment with interferon beta or glatiramer acetate within 2 months of study initiation

• Prior treatment with natalizumab or rituximab

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks
• CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
• CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability.		12 weeks, with 4 weeks to follow-up	Yes
Secondary	Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)		12 weeks, with 4 weeks to follow up.	No